QUIDEL ORTHO: Device Recall
Recall #Z-0902-2025 · 12/05/2024
Recall Details
- Recall Number
- Z-0902-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- QUIDEL ORTHO
- Status
- Ongoing
- Date Initiated
- 12/05/2024
- Location
- Rochester, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,541 units (1,125 US, 416 OUS)
Reason for Recall
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Product Description
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. One sales unit contains 5 cartridges. Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit. Component: No, not a component
Distribution Pattern
Domestic: Nationwide Distribution International: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom,
Other Recalls by QUIDEL ORTHO
- Class II: Risk 12/05/2024